Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine

February 6, 2008 updated by: Ariston Pharmaceuticals, Inc.

Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study

The purpose of this migraine prevention study is to evaluate the efficacy and safety of AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and compared to a baseline period as measured by a reduction in the number of migraine days.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Migraine patients may experience repeated migraine attacks, lasting from four hours to three days or more. Each attack is characterized by severe pain, typically on one side of the head and often involves a number of other symptoms, including pain with a pulsating or throbbing quality, nausea or vomiting, sensitivity to light and sound, visual disturbances or aura. Currently the management of migraine may be either acute treatment or prophylaxis. Acute migraine treatment aims at aborting or reversing already present migraine symptoms with acute administration of medicine such as with triptans, whereas migraine prophylaxis aims to reduce the frequency and severity of migraine attacks over time through chronic medication.

The overall protocol design and outcome measurements of this study follow the guidelines and durations recommended by the International Headache Society for prophylaxis studies of migraine medications.

The study ARPH-CL-03 is a multicenter, randomized, double-blind, three parallel group design with moderate to severe migraine patients to assess the ability of daily administration of AST-726 at one of two doses to reduce the number of headache days in a 4 week period more than in patients that receive a placebo. AST-726 and the placebo will be self-administered by intranasal spray daily for 12 weeks. Among other efficacy and safety assessments, patients will have be asked to collect information on a daily migraine diary.

Patients will be instructed on the allowed use of acute migraine medications during this study.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Hameenkatu 18 6th Floor, Tampere, Finland, 33200
        • Headache Center, Tammertutka
      • Itsenalsyydenk. 33, Pori, Finland, 28100
        • Porin Laakerikeskus
    • Seinajoki
      • Koskenalantie 16, Seinajoki, Finland, 60220
        • Mediwest Research Centre Oy
    • Turku
      • Brahenkatu 11D, Turku, Turku, Finland, 20100
        • Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)
    • Vainonkatu 30
      • Jyvaskyla, Vainonkatu 30, Finland, 40100
        • Suomen Terveystalo Jyvaskyla
  • Netherlands
      • Geerdinksweg 141, Hengelo, Netherlands, 7555
        • Ziekenhuisgroep Twente, Afdeling Neurolgie , Locatie Streekziekenhuis Midden Twente
      • Geldrop, Netherlands, 5664
        • St Anna Hospital, Bogardeind 2
      • Weg door Jonkerbos 100 SZ Nimegen, Netherlands, 6532
        • Canisius Wilhelmina Hospital, Afdeling C02.04
    • Zwolle
      • Groot Wezenland 20, Zwolle, Netherlands, 8000
        • Isala Kliniek
  • United Kingdom
      • Wellingborough, United Kingdom, NN8 4RW
        • Albany House Medical Centre, 3 Queen St.
    • Cornwall
      • Fowey, Cornwall, United Kingdom, PL23 1DT
        • The Fowey River Practice; Rawlings Lane
      • Penzance, Cornwall, United Kingdom, TR18 4JH
        • The Alverton Practice, 7 Alverton Terrace
      • Saltash, Cornwall, United Kingdom, PL 12 6DI
        • Saltash Health Centre
    • Eky
      • Soham, Eky, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
    • Lancashire
      • Farnworth BL4 9QZ Bolton, Lancashire, United Kingdom, BL4 9QZ
        • Stonehill Medical Centre, Piggot st.
    • Middlesex
      • Ashford, Middlesex, United Kingdom, TW15 3EA
        • Stanwell Road Surgery, 25 Stanwell Road
      • Harrow, Middlesex, United Kingdom, HA3 7LT
        • The Circle Practice/Belmont Health Centre
    • Plymouth
      • Devon, Plymouth, United Kingdom, PL6 7TH
        • Woolwell Medical Centre
    • Surrey
      • East Horsley, Surrey, United Kingdom, KT24 6QT
        • The Medical Centre, Kingston ave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary Inclusion Criteria:

  1. Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
  2. Has had migraines for at least 6 months prior to study enrollment period.
  3. Migraines began before age 50.
  4. Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 months prior to study enrollment.
  5. Has 2 to 10 attacks in 30 days during the Baseline Period.

Additional inclusion criteria in protocol

Primary Exclusion Criteria:

  1. Has headache equal to or greater than 18 days per month.
  2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
  3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine [DHE]) greater than 15 days per month.
  4. Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
  5. Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.

Additional exclusion criteria in protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C
Drug: AST-726 Placebo
Experimental: A
Drug: AST-726 Low dose
Experimental: B
Drug: AST-726 High dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome variable will be change in number of migraine headache days during standardized 30-day observation periods during treatment period and baseline period. The number of headache days reported in the patient diary will be standardized.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period
Time Frame: 4 weeks
4 weeks
2 The number of migraine headache attacks in each treatment period
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ariston Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: W. M. Mulleners, Canisius-Wilhelmina Zeikenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2008

Last Update Submitted That Met QC Criteria

February 6, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARPH-Cl-03
  • Eudract no: 2005-003349-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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